USA-based drug major Pfizer says that its oral selective COX-2 inhibitor Celebrex (celecoxib) has been granted a UK label extension for use in the symptomatic relief of ankylosing spondylitis. This follows a positive outcome from the European Medicines Agency (EMEA) under the mutual recognition process, which involved a total of 17 European countries.
Pfizer said that the agent, which received US Food and Drug Administration approval for AS in July 2005 (Marketletters passim), is one of the most extensively studied COX-2 inhibitors, adding that it has amassed clinical data from trials involving 34,000 patients to support the product's positive risk/benefit profile.
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